Antifungal Cresemba (isavuconazole) approved for aspergillosis patients in China
pharmafile | January 13, 2022 | News story | Business Services |
Basilea Pharmaceutica, announced that its license partner, Pfizer, has received a Drug Approval License from the National Medical Products Administration (NMPA) in China for its antifungal Cresemba (isavucanazole), for the treatment of adult patients with invasive aspergillosis.
This is the second approved indication for oral Cresemba in China, following the approval for the treatment of adult patients with invasive mucormycosis, which was received in December 2021. Pfizer submitted separate marketing authorisation applications for the intravenous formulations of Cresemba for the treatment of invasive aspergillosis and mucormycosis, and these are under regulatory review by the Center for Drug Evaluation at the NMPA.
The license agreement between Basilea and Pfizer covers Europe (excluding the Nordic countries), Russia, Tukey, Israel, as well as China (including Hong Kong and Macao), and sixteen countries in the Asia Pacific region.
David Veitch, Basilea’s CEO said: “Invasive aspergillosis is the more frequent infection than mucormycosis and we congratulate our partner Pfizer on this second approval of Cresemba in China, thus broadening the range of approved indications. Invasive fungal infections can pose a serious threat to patients.
“With this approval, patients in China who are suffering from invasive aspergillosis will now have access to a treatment that can help to address their unmet needs. China is a very important commercial market for Cresemba, accounting for approximately 20 percent of global sales for newer antifungals.”
Cresemba has been approved in more than 60 countries to date and is currently marketed in 56, including the US, most EU member states and additional countries inside and outside of Europe.
Lina Adams
